GERMANY Law and Practice Contributed by: Clemens Tobias Steins, Michael Pfeifer, Daniel Grohs and Bianca-Lucia Vos, HOFFMANN EITLE
2.4 Publicly Available Drug and Patent Information The Federal Institute for Drugs and Medical Devices publishes a monthly updated anonymised list of pend ‑ ing applications for marketing authorisations; grant ‑ ed MAs are compiled and publicly accessible in the AMIce database. No notice or other information will be given to the MA holder. Marketed pharmaceuticals are included in the Lauer- Taxe, which is updated twice a month and becomes effective a few days after publication. 2.5 Reimbursement and Pricing/Linkage Markets MAs and reimbursements are granted without con ‑ sideration of the patent status (no patent linkage system). The private company IFA is entrusted with issuing tag numbers for pharmaceuticals (PZN) and compiles data on commercialised pharmaceuticals (which is then published, eg, in the Lauer-Taxe). IFA thereby acts at least partly as a gatekeeper against generic launch (see Germany Trends and Develop- ments for details). Public health insurers may, in theory, resort to indi ‑ cation-specific tendering, because allowing generic bidding on unlimited tenders may constitute an act of infringement if use patents still cover certain indica ‑ tions. There are no differences between biosimilars and generics in terms of infringement (see 2.1 Infringing Acts ). 3.2 Data and Regulatory Exclusivity There are no differences between biosimilars and generics regarding data and regulatory exclusivity (see 2.2 Regulatory Data and Market Exclusivity ). 3.3 Acceptable Pre-Launch Preparations The experimental use and Bolar exemptions under German law also cover biosimilars (see 2.3 Accept- able Pre-Launch Preparations ). 3. Biosimilar Market Entry 3.1 Infringing Acts
3.4 Publicly Available Drug and Patent Information There are no differences between biosimilars and generics in terms of publicly available drug and pat ‑ ent information (see 2.4 Publicly Available Drug and Patent Information ). 3.5 Reimbursement and Pricing/Linkage Markets There are no differences between biosimilars and generics regarding reimbursement and pricing/link ‑ age markets (see 2.5 Reimbursement and Pricing/ Linkage Markets ).
4. Patent Term Extensions for Pharmaceutical Products
4.1 Supplementary Protection Certificates In Germany, supplementary protection certificates (SPCs) are available for patents relating to active ingredients of medicinal products as well as plant protection products. The holder of a patent for a new medicinal product or plant protection product must refrain from placing it on the market until it has received the necessary authorisation. This reduces the period of effective protection of the patent. SPCs have been established to partially offset this loss of time to monetize the invention. German SPCs for medicinal products are governed by Regulation (EC) No 469/2009, which has been trans ‑ lated into national law. Relevant provisions can be found in Sections 16a and 49a of the GPA. Any active ingredient or combination of active ingre ‑ dients protected by a patent and subject matter prior to being placed on the market as a (human or veteri ‑ nary) medicinal product may be the subject matter of an SPC. Article 3 of Regulation 469/2009 sets out the require ‑ ments for obtaining an SPC for a medicinal product. The product (ie, the active ingredient or combination of active ingredients of the approved medicinal prod ‑ uct) must be “protected” by a basic patent in force (Article 3 (a)). There is no limitation to certain types of patents; a suitable basic patent may protect the
69 CHAMBERS.COM
Powered by FlippingBook